BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    JenaValve Production Limited

    Reg #: 3011894841 · FEI: 3011894841 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    JenaValve Production Limited
    Registration Number
    3011894841
    FEI Number
    3011894841
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit 9A Astley Way
    City
    Swillington Leeds
    Country
    GB

    Regulatory Submissions

    PMA Number
    P250024

    Owner / Operator

    Firm Name
    JenaValve Technology, Inc.
    Operator Number
    10051384
    Address
    4 Cromwell
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Tonya Porter

    Products

    Device Name Product Code
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT

    Proprietary Names

    JenaValve Trilogy Transcatheter Heart Valve System JenaValve Trilogy Loading Tools Trilogy Introducer Sheath Trilogy Transcatheter Heart Valve (THV) Trilogy Delivery Catheter

    Establishment Types

    Manufacture Medical Device